FDA May Re-Classify Vaginal Mesh as High-Risk Medical Device

April 30, 2014 — The U.S. Food and Drug Administration (FDA) has issued two proposed orders that would re-classify vaginal mesh from a moderate-risk device (class II) to a “high-risk” device (class III) and require a pre-market approval application for the FDA to evaluate safety and effectiveness of new devices.

Approximately 50,000 vaginal mesh lawsuits are currently pending in state and federal court against several manufacturers. Several plaintiffs have already been awarded multi-million dollar jury verdicts.

Vaginal mesh is used to treat pelvic organ prolapse and stress urinary incontinence, but the proposed changes would only affect devices used for prolapse surgery. The first time the FDA considered re-classifying vaginal mesh as a high-risk device was in September 2011, two months after the agency warned that serious complications were “not rare.”

Until now, manufacturers have gained approval for many vaginal mesh products under the FDA 510(k) “fast-track” approval process, which allows new devices on the market without safety studies so long as they are similar to an existing device. The process came under scrutiny after manufacturers used 510(k) applications based on products that were pulled off the market for safety concerns.

William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health:

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products. If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”

Do I have a Vaginal Mesh Lawsuit?

The Schmidt Firm, PLLC is currently accepting vaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by vaginal mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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